MedTrace Logo

Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis

NCT05346718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-14

No results posted yet for this study

Summary

The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms.

Conditions

  • Allergic Rhinitis
  • Seasonal Allergic Rhinitis
  • Ragweed Allergy
  • Birch Pollen Allergy

Interventions

OTHER

Ragweed pollen, birch pollen, clean air (placebo)

Participants are exposed for 4 hours in the Fraunhofer Allergen Challenge Chamber with varying pollen concentrations of ragweed or birch pollen and once with clean air, serving as a placebo exposure.

Sponsors & Collaborators

  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Principal Investigators

  • Jens M Hohlfeld, Prof. Dr. · Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05346718 on ClinicalTrials.gov